MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 4, 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	208-24-18
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.Concomitant device(s): 200-02-35 - three peg patella 35mm, 1658017.204-34-08 - fluted stem extension 80l x 14 mm, 1674713.204-40-12 - stem extension w/slot 120l x20 mm, 1051537.204-63-05 - tibial augment block 1/2-sz 3 5mm, 1885241, 1885243.208-01-04 - cc femoral sz 4, 8581248.208-04-42 - trap tray, offset beta cem., sz 4f/3t, 1706938.208-04-76 - screw, offset, szhh, 1153926.208-06-04 - cc distal fem augment sz 4, 10mm, 1351851, 1931859.208-07-04 - cc posterior fem augment sz 4, 5mm, 1813897.208-09-05 - cc stem ext adaptor 5 degree, 2066882.
Event or Problem Description
It was reported via legal that a male patient had right knee replacement index surgery on (b)(6) 2011 and a revision surgery on (b)(6) 2019 approximately 8 years after implant.No further information was reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b5, g1, h6 - health effect clinical code, component code, investigation findings and h7.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, the patient experienced an unknown issue.As a result, the patient underwent a right knee revision approximately 8 years after initial implantation.No further patient impact reported.No further information available.

• Brand Name: CC TIBIAL INSERT SZ 4, 18MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 3523771140
• MDR Report Key: 15535790
• Report Number: 1038671-2022-01225
• Device Sequence Number: 20136682
• Product Code: JWH
• UDI-Device Identifier: 10885862054364
• UDI-Public: 10885862054364
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2013
• Device Model Number: 208-24-18
• Device Catalogue Number: 208-24-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male